Updated on 13 August 2012
The drug's safety and effectiveness to treat DME were established in two clinical studies
Singapore: The US Food and Drug Administration has approved Lucentis (ranibizumab injection) by US-based Genentech for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes.
An injection administered once a month by a healthcare professional, Lucentis is intended to be used along with good diabetic blood sugar control. DME is a condition in which fluid leaks into the macula, the center part of the retina where sharp, straight-forward vision occurs. The fluid makes the macula swell, causing vision to blur.
According to the Centers for Disease Control and Prevention, diabetes (type 1 and type 2) affects about 26 million people in the United States and is the leading cause of new blindness among people ages 20 to 74 years. In 2010, 3.9 million adults diagnosed with diabetes reported trouble with their vision.
"Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema," said Dr Renata Albrecht, director of the Division of Transplant and Ophthalmology Products in FDA's Center for Drug Evaluation and Research. "Today's approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease."
The drug's safety and effectiveness to treat DME were established in two clinical studies involving 759 patients who were treated and followed for three years. Patients were randomly assigned to receive monthly injections of Lucentis at 0.3 milligrams (mg) or 0.5 mg, or no injections during the first 24 months of the studies. After 24 months, all patients received monthly Lucentis either at 0.3 mg or 0.5 mg.